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OpenTrials
Completed

NCT Number: NCT00879138

Efficacy and Safety of VA106483 in Elderly Males

A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.

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Key information

Conditions

Nocturia Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

65 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Veeda Clinical Research

Plymouth, United Kingdom

About this study

VA106483 is a selective vasopressin V2 receptor agonist which is currently under development for the treatment of nocturia in males. This study examines the pharmacological action of VA106483 on markers of clinical efficacy (urine volumes and osmolality) and safety markers (coagulation factors and haemodynamics). The study will also assess the pharmacokinetics in the study population. The study design includes both cross-over and parallel phases so that pharmacodynamic and pharmacokinetic parameters can be assessed following both single and repeat dosing. Three dose levels will be given.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males 65 years and above with history of nocturia

Exclusion criteria

  • Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
  • Participation in any other clinical study within 30 days
  • Intake of non-prescription medication within 14 days

Treatment and study plan

VA106483

Drug

Sugar pill

Drug

Primary outcomes

  1. Pharmacodynamic profile of VA106483

Secondary outcomes

  1. Pharmacokinetic profile of VA106483

  2. Safety and tolerability of VA106483

Sponsors and collaborators

Lead sponsor

Vantia Ltd

Industry

Collaborators

  • Veeda Clinical Research

Registry information

Official study title

A Double-blind, Placebo-controlled Dose Response Study to Investigate Pharmacodynamics and Pharmacokinetics of Single and Repeated Oral Doses of VA106483 in Elderly Male Subjects

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 9, 2009
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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